Combat Medical is proud to announce that our Phase 3 clinical trial of HIVEC®-HEAT for patients with BCG-unresponsive non-muscle-invasive bladder cancer, has received ethical and MHRA (Medicines and Healthcare products Regulatory) approval. HIVEC®-HEAT has also been positively reviewed by the U.S. FDA, so we’re delighted to have reached this next important milestone and have the green light for patient recruitment. We’re expecting the first patient to be enrolled by the end of this month.
The Urgent Need for New Treatments in NMIBC
According to 2022 data from the World Cancer Research Fund*, bladder cancer is the 9th most common cancer globally, and NMIBC accounts for approximately 75% of new diagnoses. Bacillus Calmette-Guérin therapy has long been a first-line standard of care. However, a considerable percentage of patients either do not respond to BCG or relapse, which poses a significant therapeutic challenge. For this population, treatment options are limited, and the prognosis can be dire.
*https://www.wcrf.org/preventing-cancer/cancer-statistics/worldwide-cancer-data/
What is HIVEC®-HEAT?
HIVEC® is a treatment method that combines chemotherapy with controlled hyperthermia. It involves circulating heated chemotherapy drugs directly into the bladder, enhancing their effectiveness by increasing drug absorption, disrupting cancer cell repair mechanisms, and promoting apoptosis.
Unlike conventional intravesical therapy, HIVEC® delivers Mitomycin-C or other agents at an optimised temperature (typically 41-43°C), exploiting heat’s synergistic cytotoxic effect. This non-surgical, bladder-preserving technique has shown promise in numerous earlier-phase studies, offering a tolerable and potentially more effective treatment alternative.
Our Groundbreaking Phase 3 Trial
The HIVEC®-HEAT Phase 3 clinical trial is a multicentre, randomised, controlled study designed to assess the efficacy and safety of HIVEC® in patients with high-risk NMIBC who have failed BCG therapy. These patients are often left with limited options, the most drastic of which includes radical cystectomy – an invasive and life-altering surgery.
Our goal is to establish HIVEC® as a viable, less invasive, bladder-sparing alternative that maintains quality of life while delivering strong oncological outcomes.
The Future of NMIBC Treatment?
For urologists, oncologists, and healthcare professionals working in bladder cancer treatment, HIVEC®-HEAT represents a vital development. This study could redefine how we treat a subset of patients who are currently underserved by existing modalities. A successful outcome would not only provide a new standard of care but also expand the therapeutic toolkit for managing NMIBC.
Medical professionals are encouraged to monitor the progress of HIVEC®-HEAT closely. We are actively collaborating with leading academic and clinical institutions across Europe and North America to ensure robust data collection and real-world applicability.
Study Design and Methodology of HIVEC®-HEAT
The trial will enroll patients diagnosed with high-risk, BCG-unresponsive NMIBC, who meet stringent eligibility criteria to ensure consistent and meaningful results.
Participants will be randomised to receive either HIVEC® therapy or a comparator treatment, which could include conventional chemotherapy or observational monitoring, depending on the standard of care at the participating site. Each treatment cycle involves instilling a chemotherapeutic agent, such as Mitomycin-C, heated to the optimal therapeutic temperature directly into the bladder through a specialised recirculation system.
The primary endpoint of the study is recurrence-free survival (RFS), while secondary endpoints include progression-free survival (PFS), overall survival (OS), safety, quality of life assessments, and bladder preservation rates. This multi-faceted design enables a comprehensive evaluation of HIVEC®’s clinical benefit.
In addition to clinical outcomes, the trial incorporates robust safety monitoring protocols, pharmacokinetic assessments, and patient-reported outcomes, ensuring that data is both scientifically rigorous and patient-centred.
HIVEC® vs. Current Standard of Care: What’s at Stake?
For patients with BCG-unresponsive NMIBC, the stakes couldn’t be higher. Many face the daunting prospect of radical cystectomy – a major surgery with significant lifestyle consequences. HIVEC® offers the possibility of bladder preservation, with a treatment approach that is minimally invasive and better tolerated.
Compared to current salvage therapies, HIVEC® has shown promising efficacy in earlier trials and real-world usage, with favourable side-effect profiles and reduced recurrence rates. The hyperthermic component significantly enhances the pharmacodynamic action of the chemotherapy agent, giving it a distinct advantage over room-temperature installations.
If HIVEC®-HEAT confirms these benefits in a larger cohort, the implications for clinical practice are profound. It would position HIVEC® as a first-choice option for patients who are currently caught in the therapeutic grey zone between failed immunotherapy and radical surgery.
Next Steps and Timeline for Enrollment
The first patient is expected to be enrolled by the end of May 2025. Over the coming months, recruitment will expand across all participating sites, aiming to enrol a statistically powered sample size for conclusive results.
A detailed timeline has been established for site activation, patient screening, and enrollment benchmarks. Watch this space for updates…
Our clinical operations team is on standby to assist referring clinicians, answer queries, and streamline the referral process for eligible patients. Medical professionals who are interested in referring patients or becoming involved as investigators are encouraged to contact us directly for further information.
